INTRODUCTION
In India, the regulatory framework for Ayurvedic drugs has remained unclear, as the forms prescribed under the Drugs Rules, 1945 (“Drugs Rules”) for obtaining an import license are not appropriate for Ayurvedic drugs.
The Madras High Court in the case of M/s Axeon Marketing India v. Assistant Commissioner of Customs has clarified the steps to be followed for the import of Ayurvedic drugs into India.
In this article we have listed the documents required and steps to be followed for the import of ayurvedic drugs into India.
The following are the essential steps to be followed, along with the required documents:
1. Submission of regulatory documents
Despite the absence of specific licensing forms, importers should proceed by compiling a comprehensive documentation to present to Customs authorities and the State Licensing Authority (“SLA”). This should include:
– Copy of invoice
– Packing list which includes the details of contents of each package
– Manufacturer’s test report
– Manufacturing license (from the country of origin)
– Specimen sample
– Label (The label must comply with the labelling requirements given under Rule 161 of the Drugs Rules.)
2. Testing by Central Drugs Standard Control Organization-accredited laboratory (“CDSCO lab”)
It is now mandatory that imported Ayurvedic drugs be tested at a CDSCO lab in India to ensure compliance with Indian safety and quality standards. The imported drug must meet standards equivalent to those applicable to similar Ayurvedic drugs already manufactured and approved in India.
– The importer is required to submit imported drug samples to a CDSCO lab, where testing will be conducted under the supervision of SLA of the state in which the laboratory is located.
– The cost for testing will be borne by the Indian importer
– If a satisfactory report is received from such laboratory, the concerned SLA will issue a certificate confirming that the manufacturing process of the imported drugs is in conformity with the process prescribed for the manufacture of ayurvedic drugs in India.
3. Submission of certificate issues by SLA
– A copy of the certificate issued by the SLA must be submitted to the Customs Department.
4. Receipt of Assistant Drug Controller’s No Objection Certificate (“NOC”)
– This document is issued by the port office of CDSCO.
– The NOC indicates that the consignment meets all applicable regulatory requirements
– Invoice, packing list, manufacture’s test report, manufacturing license, specimen sample, label may be examined before giving NOC by port office.
CONCLUSION
A guidance document governing the import of Ayurvedic drugs already existed, however, it did not mandate testing of the imported drug by a CDSCO lab. After the recent judgment by the Hon’ble Madras High Court, this requirement has now been made compulsory. Therefore, importers must comply with this requirement, along with all other steps outlined above, to obtain import clearance.
